Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union. Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans

Table of Contents:
Part 1: Introduction How Oncology Drug Development Differs from Other Fields, 3 Ann T. Farrell, John Leighton, Grant Williams, and Richard Pazdur Part 2: Drug Discovery Natural Products, 13 Riyaz N.H. Shah and Stanley B. Kaye History of the National Cancer Institute Drug Discovery Program, 25 Edward A. Sausville and Jill I. Johnson Combinatorial Chemistry in Anticancer Drug Development, 43 Ian R. Hardcastle and Roger J. Griffin Protein Crystallography in Drug Discovery, 57 Martin Noble and Jane Endicott High-Throughput Screening, 69 Ramesh Padmanabha and Martyn Banks Bioinformatics and Data Mining in Support of Drug Discovery, 79 Jeffrey Augen Genomics and Drug Development, 97 Robert H. tePoele and Paul Workman The Application of Proteomics to Drug Development, 117 Lasantha R. Bandara and Sandy Kennedy Part 3: Preclinical Models The Role of In Vitro Cell Line, Human Xenograft, and Mouse Allograft Models in Cancer Drug Development, 129 Theodora Voskoglou-Nomikos, Stefan D. Baral, and Lesley K. Seymour Drug-Drug Interaction Studies During Early Clinical Drug Development, 149 Jochen Kuhlmann and Christoph Wandel Gene-Targeted Mice in Anticancer Drug Development, 163 Thomas M. Donnelly Part 4: Analytical Laboratory Techniques Modern and Practical Guide for Bioanalysis, 187 Surendra K. Bansal and Zhenmin Liang Good Laboratory Practice and the Development of Anticancer Agents, 195 Jinee D. Rizzo Part 5: Delivery Systems Pharmaceutical Formulation of Novel Anticancer Agents, 205 Bastiaan Nuijen Liposomal Drug Carriers for Cancer Diagnosis and Therapy, 225 Martin Brandl Polymer-Drug Conjugates, 239 Ruth Duncan Prodrug Drug Development and Retrometabolic Engineering, 261 Daniel R. Budman Pharmacokinetics and Pharmacodynamics in Anticancer Drug Development, 269 Chris H. Takimoto Part 6: Clinical Studies Allometric Scaling: Predicting Pharmacokinetic Parameters of Drugs in Humans from Animals, 285 Iftekhar Mahmood Phase I Clinical Trial Design, 297 Lawrence V. Rubinstein and Richard M. Simon Phase I Trial Design: Considerations in the Pediatric Population, 309 Elizabeth Fox and Peter C. Adamson Measurements of Endpoints in Phase I Drug Design: Toxicity versus Alternatives, 319 Jerry M. Collins and Merrill J. Egorin Tumor Response Evaluation in Clinical Trials: RECIST, 331 A. Dimitrios Colevas Pharmacogenetics and Cancer Chemotherapy, 343 Hany Ezzeldin and Robert B. Diasio Designs for Phase II and Phase III Cancer Drug Studies, 379 Gary L. Rosner and Donald A. Berry Part 7: Specific Issues in Drug Development Data Verification and Scientific Auditing, 395 Raymond B. Weiss Role of the Cooperative Groups in Drug Development, 403 Christopher W. Ryan and Richard L. Schilsky Drug Development in the Elderly, 411 Stuart M. Lichtman